Monograph Details
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Respiratory Tract
> Cough and cold
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SUDAFED PE SEVERE COLD |
| Manufacturer |
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McNeil Consumer & Specialty Pharmaceuticals |
| Legal Classification |
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OTC |
| Pharmacological Class |
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Analgesic + antihistamine + sympathomimetic. |
| Generic Name |
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Acetaminophen 325mg, diphenhydramine HCl 12.5mg, phenylephrine HCl 5mg; per caplet. |
| Also |
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• SUDAFED PE NIGHTTIME COLD
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| Indications |
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Nasal congestion, rhinorrhea, headache, sore throat, fever. |
| Children |
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<6yrs: individualize. 6–11yrs: 1 caplet every 4 hours as needed; max 5 caplets/24hrs. |
| Adults |
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2 caplets every 4 hours as needed; max 12 caplets/24hrs. |
| Contraindications |
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Within 14 days of MAOIs. Concomitant acetaminophen or diphenhydramine (including topical) products. |
| Precautions |
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Cardiovascular disease. Hypertension. Liver disease. Thyroid disease. Glaucoma. Diabetes. Asthma. Lower respiratory disorders. GI or GU obstruction. |
| Interactions |
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See Contraindications. Increased risk of liver damage with ≥3 alcoholic drinks/day. Hypertensive crisis with MAOIs. β-blockers may increase the pressor effects of sympathomimetics. Other CNS depressants potentiated. Antihypertensives antagonized. |
| Adverse Reactions |
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Drowsiness, anticholinergic effects, nervousness, dizziness, insomnia, excitability in children. |
| How Supplied |
Severe Cold—12, 24
Nighttime Cold—20 |
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